PATTERNS EMERGING FROM CHAOS - Lex Jansen · Using patterns to connect form items, SDTM and ADaMvariables to a central hub ensures changes to metadata allow connectivity to remain

© 2018 PAREXEL INTERNATIONAL CORP.

PATTERNS EMERGING FROM CHAOS6th June 2018, PhUSE US Connect, RaleighAlan Cantrell

© 2018 PAREXEL INTERNATIONAL CORP. / 2

AGENDA • Introduction•Historical changes to structure

•Metadata Linkage•Metadata changes and impact

•Governance and patterns

•Conclusion


• Mapping by declaration to concepts

• Allows End to End (E2E) data flow dry-run without data

• Study teams worry about the what not the how

• ISO 21090 BASED CLINICAL RECOGNIZABLE CONCEPTS

• DATA IS MAPPED TO AND FROM A HUB

• USABLE FOR CDISC AND OTHER DATA MODELS

INTRODUCTION

(HUB)

CDASH / Data Collection

AEACNOTHOther Action Taken

(SPOKES)

AE Domain DefinitionPattern Coded Item

Concept ACNOTHOther Action Taken

ADaM / Data AnalysisAEACNOTH Other Action TakenAEACNOFL Other Action Taken Flag

SDTM / Data Tabulation

AEACNOTHOther Action Taken

DISP

LAYN

AMETRANSLATION.

DISPLAYNAME

GROUP.

DISPLAYNAME


HISTORICAL CHANGES TO STRUCTURE - I

SpecificationSource Metadata

Target Metadata

A specification documents the

requirements and rules for mapping

from source to a targetThe specification is dependent on the

source and target metadata. If either

changes the specification needs to be

adapted – it acts as a bridge

Source metadata could be updated by

a protocol amendment or change in

expectations by sponsor


HISTORICAL CHANGES TO STRUCTURE - II

SpecificationSource Metadata

Target Metadata

Example

Protocol Version 1

Adverse Event Start Date collected in format ddmmmyyyy, e.g. 06JUN2018

Protocol Amendment 1

Adverse Event Start Time is added to the data collection instrument, e.g. 14:00 and Adverse Event Start Date collection format is changed to yyyymmdd, e.g. 20180606


METADATA LINKAGE

A pattern facilitates the reading in of variable metadata and outputting of variable metadata

PATTERNDATEITEM

TIME.HHMM

ITEM.DDMMMYYYY

ITEM.YYYYMMDDHHMM

ITEM.YYYYMMDD

In turn the pattern enables the generation of code to implement this transformation

StartDateCode


METADATA CHANGES AND IMPACT - I

DCIADVERSE EVENTS

START DATE

START TIME

STDTC

ADVERSE EVENTS DOMAIN

DEFINITION

AESTDTC

ADAMADAE

AESTDTCASTDTCASTDT

ASTDTFStartDateCode

SDTMAE

AESTDTC

StartDateCode


METADATA CHANGES AND IMPACT - II

Pre-protocol amendment

Post-protocol amendment

Changing the format of the source metadata retains the connectivity between the data collection instrument and SDTM but updates the related source code


METADATA CHANGES AND IMPACT - III

In addition, a change to the Statistical Analysis Plan could impact the method for imputing the analysis date and flags such as ASTDT / ASTDTF


GOVERNANCE AND PATTERNS

Metadata is stored within the MDR and is version controlled

Updated metadata is used to generate updated mapping code

Code related to metadata is retained using subversion

StartDateCodeStartDateCodeStartDateCode


CONCLUSION

Using patterns to connect form items, SDTM and ADaM variables to a central hub ensures changes to metadata allow connectivity to

remain in place.

Patterns emerging from chaos

QUALITY EFFICIENCYCONSISTENCY


QUESTIONS

For more information:

Alan CantrellAssociate Director, Statistical Programming

[email protected]

Come and see us at PAREXEL’s booth!

Visit our MDR resource portal at: https://www.parexel.com/solutions/clinical-research/global-data-operations/clinical-metadata-repository-mdr

https://www.parexel.com/solutions/clinical-research/global-data-operations/clinical-metadata-repository-mdr


THANK YOU


PATTERNS EMERGING FROM CHAOS - Lex Jansen · Using patterns to connect form items, SDTM and ADaMvariables to a central hub ensures changes to metadata allow connectivity to remain

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